To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes.
Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 or the Competitive DRUGS Act of 2019
This bill authorizes the Federal Trade Commission to initiate a proceeding against parties to an agreement resolving or settling a patent infringement claim in connection with the sale of a drug. Such an agreement is generally presumed to be an unfair method of competition and is a violation of this bill if the filer of the generic drug application receives something of value and agrees to limit or forgo research, development, manufacturing, marketing, or sales of the generic drug.
However, an agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market the generic drug prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on a claim that the generic drug infringes a patent. An agreement if also exempt if the agreement's pro-competitive benefits outweigh its anticompetitive effects.
The bill establishes penalties for violations of the bill.
Placed on the Union Calendar, Calendar No. 576.
Read twice and referred to the Committee on the Judiciary.
Introduced in House
Introduced in House
Referred to the Subcommittee on Health.
Referred to the Committee on Ways and Means, and in addition to the Committees on Energy and Commerce, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Ways and Means, and in addition to the Committees on Energy and Commerce, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Ways and Means, and in addition to the Committees on Energy and Commerce, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
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